Events

Retiro De Equipo (Recall) de Flexi-Slip endotracheal tube stylets(Intended for use in facilitating intubation of tracheal tubes.)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Teleflex Medical Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-00874-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-09-08
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00874-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    There have been reports of the plastic coating of the stylet splitting and/or breaking off of the stylet. this may result in a piece of plastic totally or partially occluding the patient’s airway and impairing ventilation, or necessitating invasive removal procedures in order to prevent complications such as atelectasis or pneumonia. over 200,000 units have been distributed and there have been 4 complaints to august 2015. this gives rise to a complaint rate of 0.00205%.No patient injuries have been reported related to this issue.
  • Acción
    Customers are asked to inspect their stock, quarantine any affected units from use and to follow the instructions on the acknowledgement form in order to have those units collected. An appropriate account credit will then be issued. This action has been closed-out on 22/08/2016.

Device

Flexi-Slip endotracheal tube stylets(Intended for use in facilitating intubation of tracheal tubes.)
  • Modelo / Serial
    Flexi-Slip endotracheal tube stylets(Intended for use in facilitating intubation of tracheal tubes.)SAP/Catalogue Number: 502501-000060Batch Numbers: 14BG27, 14FG03ARTG Number: 214058
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd